Controlled Cord Traction During Third Stage of Labor (CCT)
This study has been completed.
Sponsor:
Universidad de la Republica
Collaborators:
Clinical and Epidemiological Research Unit Montevideo
Institute for Clinical Effectiveness and Health Policy
Information provided by:
Universidad de la Republica
ClinicalTrials.gov Identifier:
NCT00781066
First received: October 27, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
Of the estimated number of 529,000 maternal deaths for the year 2000, 132,000 (25%) were caused by postpartum hemorrhage (PPH); 99% of these deaths occurred in low-income countries. Where maternal mortality is high and resources are limited, the introduction of low-cost, evidence-based practices for primary prevention of PPH is an urgent need. Controlled cord traction (CCT) is actively promoted in combination with prophylactic uterotonics for the prevention of PPH. While the administration of uterotonics has been proven effective, there is no evidence of CCT being beneficial or safe. The investigators propose this study to evaluate two primary questions:
- In women having term, single vaginal deliveries in hospital settings, in whom the third stage is managed with prophylactic oxytocin, does CCT produce a clinically significant reduction in the incidence of postpartum blood lose?
- In these women, does CCT produce a clinically significant increase in the incidence of severe complications, including uterine inversion or the need for subsequent surgical evacuation of retained placental tissues and membranes (curettage or manual removal)?
To answer these two questions we designed two arms randomized controlled trial.
| Condition | Intervention | Phase |
|---|---|---|
|
Postpartum Hemorrhage |
Procedure: Controlled cord traction Procedure: No controlled cord traction |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Controlled Cord Traction During Third Stage of Labor: Pilot Trial |
Resource links provided by NLM:
Further study details as provided by Universidad de la Republica:
Primary Outcome Measures:
- Postpartum blood loss [ Time Frame: a minimum of 20 minutes after delivery ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Manual removal of placenta [ Time Frame: within 1 hour after delivery ] [ Designated as safety issue: Yes ]
- Uterine inversion [ Time Frame: within 30 minutes after delivery ] [ Designated as safety issue: Yes ]
- Uterine curettage [ Time Frame: before hospital discharge ] [ Designated as safety issue: Yes ]
- Blood transfusion [ Time Frame: before Hospital discharge ] [ Designated as safety issue: No ]
- Length of third stage of labor (minutes) [ Time Frame: until expulsion of the placenta ] [ Designated as safety issue: No ]
| Enrollment: | 200 |
| Study Start Date: | January 2007 |
| Study Completion Date: | September 2007 |
| Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Controlled cord traction (CCT)
|
Procedure: Controlled cord traction
|
|
Active Comparator: 2
No CCT
|
Procedure: No controlled cord traction
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 18 years old or more
- Single pregnant women during third trimester of prenatal care or in early first stage of labor at the participating hospital (Cervical dilatation ≤ 6 cm).
- No indication of cesarean section
- No contraindications for receiving prophylactic uterotonics
- Gestational age ≥ 37 weeks
Additional Inclusion Criteria for Randomization
- Imminent vaginal delivery
Exclusion Criteria:
- Severe acute complications during labor requiring emergency actions (e.g., eclampsia, hemorrhage, or any other complications that imply serious difficulties according to the judgment of the attendant)
- No consent to participate in the study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00781066
Locations
| Uruguay | |
| Clinica's Hospital Manuel Quintela of the University of the Republic of Uruguay | |
| Montevideo, Uruguay, 11600 | |
| Pereira Rossell Hospital | |
| Montevideo, Uruguay, 11600 | |
Sponsors and Collaborators
Universidad de la Republica
Clinical and Epidemiological Research Unit Montevideo
Institute for Clinical Effectiveness and Health Policy
Investigators
| Principal Investigator: | Alicia V Aleman, MD | Clinical and Epidemiological Research Unit Montevideo |
More Information
Additional Information:
No publications provided
| Responsible Party: | Alicia Aleman, Clinical and Epidemiological Research Unit Montevideo |
| ClinicalTrials.gov Identifier: | NCT00781066 History of Changes |
| Other Study ID Numbers: | CCT 06-00051, D43TW005492 (NIH grant number) |
| Study First Received: | October 27, 2008 |
| Last Updated: | October 27, 2008 |
| Health Authority: | Uruguay: Comite de Etica |
Keywords provided by Universidad de la Republica:
|
POSTPARTUM HEMORRHAGE PREVENTION CORD TRACTION THIRD STAGE LABOR |
Additional relevant MeSH terms:
|
Hemorrhage Postpartum Hemorrhage Pathologic Processes Obstetric Labor Complications |
Pregnancy Complications Puerperal Disorders Uterine Hemorrhage |
ClinicalTrials.gov processed this record on June 18, 2013